Did FDA Cross the Line in Its 2009 Cheerios-Case Finding?

Industry Awaits Agency's Final Word on General Mills' Lower-Cholesterol Claim

Any day now, the Food and Drug Administration could make a final ruling on one of the more talked-about food cases in recent years -- its assertion in 2009 that General Mills was out of bounds when it claimed that its beloved Cheerios cereal could lower cholesterol 4% in six weeks.

General Mills quietly removed the claim, replacing it with a more vague statement on some packages of its multiple Cheerios brands that the toasted-oat cereal "can help lower cholesterol." A footnote states that 3 grams of soluble fiber from whole-grain-oat foods "like Cheerios," along with a diet low in saturated fat and cholesterol "may reduce the risk of heart disease."

Cheerios has since removed the cholesterol claim from is packaging.

There's no telling if the FDA will stick to its initial finding, soften it or retract it. And it's anyone's guess how General Mills will react, because both parties have remained relatively quiet on the matter. "We're currently in discussions with FDA, and we look forward to reaching a resolution soon," a General Mills spokeswoman told Ad Age in an email last week, which also referenced a statement the food giant made in 2009 noting that the cholesterol claim had been in place for two years and that a "clinical study supporting Cheerios' cholesterol-lowering benefit is very strong."

One expert says the FDA, whose warning came from a Minneapolis field office, overstepped its bounds and might be looking for a way to slowly retract the action.

"The initial letter that went out caught the FDA management by surprise," said Peter Pitts, an FDA associate commissioner during the Bush administration. "Agency policy is not supposed to be made by a mid-level office ... via letter."

In his opinion, the FDA is now "looking for a graceful way to save face."

In its May 2009 warning letter, the FDA raised eyebrows across the food industry when it asserted that the cholesterol claim amounted to promoting the cereal as a "drug because the product is intended for use in the prevention, mitigation and treatment of disease." The agency allows health claims associating grain products with reduced risk of heart disease. But the FDA said General Mills "misbranded" the cereal, pointing to an affiliated website it said failed to include references to other good diet practices, like eating fruits and vegetables and keeping fat levels low, according to the letter.

The warning led to a lawsuit by several consumers now seeking class-action status who allege that they were misled by General Mills into buying a product that "lacked values, characteristics, uses or benefits they were led by General Mills to believe they had." General Mills has asked the court to dismiss the case, saying in legal filings among other things that "plaintiffs received exactly what they paid for -- a breakfast cereal that may lower cholesterol -- and they may not use this action to obtain any more."

The suit, filed in a federal court in New Jersey, has mostly been put on hold until the FDA makes a final determination. Pressed by the court on when the FDA could rule, General Mills attorney Andrew Tulumello said in November that the case is still "open and active," according to a transcript of a status hearing. He added that "we don't have a clear sense of when that final decision will be coming, but the FDA has told us that it will be coming."
The FDA told Ad Age it "cannot provide any comments about ongoing investigations."

The court, meantime, on March 2 allowed discovery to proceed in the case and scheduled a hearing for April 4. Plaintiff's attorney Joe Whatley Jr. told Ad Age he would be seeking details from General Mills on the studies it used to make the cholesterol claim. "If companies go out and make misrepresentations ... then they've got to pay the price for it," he said.

Mr. Pitts, who is not involved in the case, said the lawsuit was "purely silly and it's wasting the court's time."